BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 8513687 · Received April 15, 2019

    Report

    Report Number
    0002648920-2019-00237
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 6, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SIGNIFICANT RADIOLUCENCY AT THE BONE CEMENT INTERFACE OF THE TIBIAL COMPONENT INDICATING LOOSENING ALONG WITH VALGUS DEFORMITY, POSSIBLY RELATED TO SUBSIDENCE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER NEXGEN CR, PS, CRA, LPS AND LCCK KNEE PACKAGE INSERT (87-6203-453-01 REV. I), LOOSENING IS A KNOWN POTENTIAL ADVERSE EFFECT OF THIS PROCEDURE; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IMPLANT DATE: 2010. CONCOMITANT MEDICAL PRODUCTS: STEMMED TIBIAL COMPONENT PRECOAT; P/N: 00598004701, L/N: 61460183 KNE-NEXGEN-FEMORALS-UNK: P/N: UNK, L/N: UNK. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2019 - 00237, 0001822565 - 2019 - 01534.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO ASEPTIC MOBILIZATION OF RIGHT KNEE APPROXIMATELY NINE YEARS POST IMPLANTATION.  ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308804 STEMMED TIBIAL COMPONENT PRECOAT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61460183

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R